Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study

Not Applicable

Completed

Conditions: Vascular Calcification
PAD

Interventions: Device: Peripheral Orbital Atherectomy System
Device: 014 Drug Coated Balloon

Registration Number: NCT02561299

Lead Sponsor: Abbott Medical Devices

Brief Summary: The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of Peripheral Artery Disease (PAD) in below the knee (BTK) lesions.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 66

Inclusion Criteria

Subject's age ≥ 18 years
Rutherford Clinical Category 3 - 5
Lesions [except in-stent restenosis (ISR)] of the distal popliteal (POP segment below the anatomical knee joint), anterior tibial, posterior tibial, tibial peroneal trunk, and peroneal arteries with ≥ 70 % diameter stenosis (DS) by angiography
Presence of clearly visible calcification in two views (both sides of vessel at the same location) evaluated angiographically- [Computerized tomography (CT) angio images may substitute to confirm distribution of calcium, if available as standard of care]
Length of calcium ≥ 25 % of total lesion length or ≥ 2 cm total length
Target lesion length up to 20 cm

Exclusion Criteria

Subject or subject's legal representative is not willing to sign an Ethics Committee approved informed consent form or comply with the study protocol requirements
Contraindicated by either device, per Instructions For Use
Presence of inflow lesion (≥ 50 % DS) or inflow not successfully treated (≥ 50% DS and/or unresolved significant angiographic complication)
Compromised outflow distal to the target lesion (≥ 70 % DS) or presence of lesion(s) or occlusion(s) located from 5 cm above the ankle to below the ankle joint space
Subject has more than 2 target vessels requiring treatment
The guide wire cannot be passed across the target lesion(s) and/or guide wire position distal to target lesion(s) outside vessel lumen
Presence of significant (≥ 70 % DS) lesion(s) or occlusion(s) not meeting the study criteria which were not successfully treated during the index procedure (≥ 50 % DS and/or significant angiographic complication)
Subject has planned amputation (including minor) of the index limb or previous major amputation of the contralateral limb
Creatinine > 2.5 mg/dL, unless on dialysis
Subject has any significant medical condition which, in the Investigator's opinion, may interfere with the subject's optimal participation in the study
Subject is participating in an investigational drug or device study that has the potential to clinically interfere with the study outcome measures
Subject is pregnant or planning to become pregnant within the study period
Subject has an unresolved severe systemic infection
Subject has an anticipated life span of less than one year
Subjects with known hypersensitivity to paclitaxel or paclitaxel related compounds
Subjects who cannot receive recommended anti-platelet and/or anticoagulant therapy
Pre-dilatation of the target lesion prior to randomization and OA treatment

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OA with adjunctive DCB angioplasty	Peripheral Orbital Atherectomy System	Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
OA with adjunctive DCB angioplasty	014 Drug Coated Balloon	Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
DCB angioplasty	014 Drug Coated Balloon	014 Drug Coated Balloon angioplasty

Primary Outcome Measures

Name	Time	Method
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure	Baseline, 6 months and 12 months post-procedure	Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. There are seven Rutherford categories used to grade the severity of peripheral artery disease; 0: asymptomatic, 1: mild claudication, 2: moderate claudication, 3: severe claudication, 4: ischemic rest pain, 5: minor tissue loss, 6: major tissue loss. The change in Rutherford category is presented as the distribution at baseline compared to that at 6- and 12-months post-procedure.
Device Success	During the procedure	Device success was defined as the ability to achieve successful delivery and deployment of the drug-coated balloon (DCB) to the target lesion as described per Instructions for Use (IFU) within 3 minutes of insertion without removal and use of an additional device. The percentage of success was based on the number of DCB devices used.
Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 6 Months and 12 Months Post-Procedure	6 months and 12 months post-procedure	A Kaplan-Meier analysis was performed to determine the percent probability that a study participant was free from CD-TLR through 6 months and 12 months.
Freedom From Unplanned, Unavoidable Major Amputation of the Index Limb at 6 Months and 12 Months Post-Procedure	6 months and 12 months post-procedure	A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from an unplanned, unavoidable major amputation of the index limb through 6 months and 12 months.
Freedom From Major Adverse Events (MAEs) at 6 Months and 12 Months Post-Procedure	6 months and 12 months post-procedure	A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event (MAE) through 6 months and 12 months. Major adverse events were defined as: clinically-driven target lesion revascularization (CD-TLR); unplanned, unavoidable major amputation of the index limb; and death within 30 days of the index procedure.
Patency of the Target Lesion at 6 Months and 12 Months Post-Procedure	6 months and 12 months post-procedure	Patency of the target lesion as reported by the Duplex Ultrasound (DUS) Core Laboratory. Vessel patency at 6 months and 12 months by Duplex Ultrasound (DUS), where patency is defined as \<50% restenosis within the treated lesion area. Patency was assessed by the DUS Core Laboratory.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (7): Fürst-Strium-Klinik Bruchsal
🇩🇪
Bruchsal, Germany
Romed Klinikum Rosenheim
🇩🇪
Rosenheim, Germany
SRH Klinikum Karlsbad- Langensteinbach GmbH
🇩🇪
Langensteinbach, Germany
Universität Leipzig
🇩🇪
Leipzig, Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen
🇩🇪
Bad Krozingen, Germany
Medical University of Graz
🇦🇹
Graz, Austria
Vascular Clinic - Hanusch Hospital
🇦🇹
Wien, Austria